The healthcare industry has been rapidly preparing for FDA compliance requirements, on all medical devices (Class I-Class III.)— With the FDA’s latest deadline being completed for Class II devices this September, are you prepared for the Class I deadline?
With each UDI deadline provide a new challenge for the medical device community. While many companies have prepared for these compliance dates and are well on their way toward UDI success, many have yet to start and are looking for a quick fix. However, UDI implementation requires long-term vision, and the process provides an opportunity for companies to adopt more efficient business practices that save money, as well as ensure compliance.
What will fall under Class I?
The last deadline for the unique device identification (UDI) is Sept. 24, 2018, for Class I devices.
“The Class I deadline is unique,” per Greg Bylo, vice president, healthcare at GS1 US. So, say you are at a hospital or physician’s office and there’s a TV up on the wall that the nurse or practitioner uses to recall your records. Well, that makes that TV a Class 1 device because it’s being used in the practice of medicine. So, when you start to think about how many Class 1 devices there are, with that type of definition, the numbers are potentially staggering. It becomes very difficult to assess how many Class 1 devices there are.”
“Additionally, a lot of companies that have never had to worry about hiring a healthcare regulatory professional on their staff are now hiring regulatory professionals because of the Class 1 deadline,” Bylo notes. “Class 1 devices can be marked with a UPC bar code if they are sold in a retail environment and still are required to have their attributes collected and submitted to the FDA Global UDI Database (GUDID.)
Bylo explains that the difference between Class I, II, and III is the II’s and III’s also must have production information included with that barcode, and that could be the lot number, batch number, serial number, and a production date.
Preparing for Class I Compliance.
A big challenge for many original equipment manufacturers (OEMs) under estimate the real effort required to stay compliant after the product has been labeled and the data has been submitted to the GUDID. Bylo mentioned the following areas that should also be addressed:
- Master data management process – Once you collect the GUDID data, a company needs to know if and when it changes and then update the GUDID within the time frame specified by the FDA.
- Labeling and packaging process – Update the Labeling and Packaging Standard Operating Procedures (SOP’s) to include the new UDI requirements.
- ERP/information systems – Are you capturing the DI and PI data when you are manufacturing and moving product? Has this addressed the appropriate transitional steps and information management steps?
- Internal audit process – Have you updated your audit procedures to select a representative product and its GUDID data and are verifying the data is accurate?
Whether you are beginning your UDI implementation or have hit roadblocks in your processes Pragmatyxs has the expertise and experience help your reach your UDI goals.